Legislation

Union legislation

The European Union has adopted a regulatory framework on GMOs to ensure the necessary levels of safety for the environment and human health as provided by the Cartagena Protocol. In the European Union GMOs are authorised for deliberate release into the environment for experimental and commercial purposes only after passing a rigorous risk assessment procedure according to the principles and methodology set out in directive 2001/18/EC (consolidate text 2021), to avoid any possible negative, unintentional or undesirable, direct or indirect, effect on the environment and on human health.
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The Italian competent authority responsible for implementing the provisions of directive 2001/18/EC is the Ministry for Ecological Transition.
  

Italian legislation

Legislative decree 8 July 2003, n. 224 (coordinated text), implementing directive 2001/18/EC, established, in accordance with the precautionary principle, appropriate measures to protect human and animal health and the environment in case of:

• deliberate release of GMOs for purposes other than placing on the market (Title II legislative decree 224/2003);
• placing on the market of GMOs as such or in products (Title III legislative decree 224/2003).
  

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Italian competent authority responsible for implementing the provisions of Legislative decree 8 July 2003, n. 224 is the Ministry for Ecological Transition.

Legislative decree 14 November 2016, n. 227 implementating directive (EU) 2015/412, amending directive 2001/18/EC as regards the possibility for Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) on their territory, amended legislative decree 8 July 2003, n. 224, introducing a mechanism that makes it possible to restrict or prohibit the cultivation of GMOs on Italian territory. To know more.

Pursuant to article 32 of legislative decree 8 July 2003, n. 224, decree of 8 November 2018 establishing the "general plan for surveillance on the deliberate release into the environment of GMOs" was issued.

For completeness of information, we mention the legislation on the use of Genetically Modified Microorganisms (GMMO).
Legislative decree 12 April 2001, n. 206 establishes measures for the contained use of GMMOs to protect human health and the environment. The national competent authority is the Ministry of Health.